Description
This technical conformance guide represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for this technical conformance guide. If you cannot identify the appropriate FDA staff, send an email tocder-edata@fda.hhs.govorcber.cdisc@fda.hhs.gov.
Scope & Applicability
Stakeholders
5Entity responsible for submitting applications under section 524B
Clinical trial team member designated to perform significant procedures.
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity to which obligations may be transferred
Regulatory Context
Attributes
8Safety Population variable
Data element for location identification
Data element for location identification
Data element for location identification
Data element for location identification
Geopolitical Entities, Names and Codes for country identification
Studies used to support safety and efficacy in the application.
Primary Efficacy Population variable
Related CFR Sections (1)
- 21CFR312.3§ 312.3 Definitions and interpretations.
(a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Nonprescription/OTC
Save Rite Medical
- 2025-11-18
Nonprescription/OTC
Medical Mega
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-11-18
Nonprescription/OTC
Shoplet
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-12
Unapproved New Drugs/Misbranded
Confer With
See Also (8)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Status: Final)